MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS MIDAS REX¿; MOTOR, DRILL, PNEUMATIC

Model Number F1/8TA15

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

During the procedure while doctor was using the medtronic midas rex drill bit b-5 (ref: f1/8ta15, lot:0223312349), the bit broke off.A new drill bit (same ref and lot) was opened to the field and soon after first being used the bit broke off as well.A new bit was opened to the field (same ref, lot: 0223312351) and finished the case.

• Brand Name: MIDAS REX¿
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st; fort worth TX 76137
• MDR Report Key: 14021096
• MDR Text Key: 288677293
• Report Number: 14021096
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2022,03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: F1/8TA15
• Device Catalogue Number: F1/8TA15
• Device Lot Number: 0223312349
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1095 DA
• Patient Sex: Female
• Patient Weight: 12 KG